Neonatal SEPSISSNAPNCT03746743
Severity Index of Neonatal Septicemia Using Score for Neonatal Acute Physiology (SNAP) II
An observational study of Neonatal SEPSIS, run by Ahmed Mahmoud Ali Ali Youssef at 1 site in Egypt.
Trial summary
To determine the effect of Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia in the Neonatal Intensive Care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal SEPSIS
- What is being tested?
- score for neonatal sepsis
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 14 Sep 2018
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.
Who may be able to join
- Type of patient: Neonates with septicemia.
- Age of patient: From 0-28 Days.
- Sex: males and females.
Who cannot join
- Neonates with proved inborn error of metabolism.
- Neonates with multiple congenital anomalies.
- Neonates with severe birth asphyxia (APGAR score <4 at 5 minutes).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Severity Index of Neonatal Septicemia of Cases Admitted at Neonatal Intensive Care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL Using Score for Neonatal Acute Physiology (SNAP) II
To determine the effect of Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia in the Neonatal Intensive Care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL.
Read the detailed description
This study will be conducted at the Neonatal intensive care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL.
Population of study \& disease condition:
Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.
Inclusion criteria:
- Type of patient: Neonates with septicemia.
- Age of patient: From 0-28 Days.
- Sex: males and females.
Exclusion criteria:
- Neonates with proved inborn error of metabolism.
- Neonates with multiple congenital anomalies.
- Neonates with severe birth asphyxia (APGAR score <4 at 5 minutes).
Methodology in details:
We will have 2 groups, each of them 50 neonates with septicemia. One group of premature neonates (32-36 weeks), the other group of full term neonates (>37 weeks).
All included Patients will be subjected to the following:
- Full history with emphasis of relevant data as follows: Date of birth, gestational age (AGA or SGA), gender, day of sepsis onset.
- Clinical assessment: Full systems examination.
- Diagnosis of sepsis:
- By abnormal Total leucocytic count or I/T ratio or CRP with clinical Suggestion (poor feeding, hepatomegaly, apnea, tachypnea, lethargy, …).
- Confirm diagnosis by blood culture. Sepsis will be considered severe if the neonate has sepsis plus one of the following: 1) cardiovascular organ dysfunction (hypotension or need for vasoactive drug) 2) 2 of the following (metabolic acidosis, increase lactic acid, oliguria, Prolonged capillary refill time) 3) Organ dysfunction (respiratory, renal, neurologic, hematologic).
- SNAP II score: For all neonates included in the study and its data collection within 24 hours from onset of sepsis, in the form of:
- Lowest mean blood pressure.
- Worst ratio of pao2/fio2
- Lowest temperature.
- Lowest serum PH.
- Occurrence of multiple seizures.
- Urine output<1 ml/kg/hour.
- Follow up: Follow up all neonates included in the study for 14 days: for morbidity and mortality.
- Diagnosis of organ dysfunction:
Respiratory: by CXR and clinical examination. CVS: by blood pressure, capillary refill time, shock and need for inotropes. Renal: by urine output, kidney function tests. Hematology: by picture of DIC or pancytopenia. Neurology: by seizures, dilated fixed pupil.
Possible Risk:
None.
Primary outcomes:
Using Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia.
Secondary outcomes:
Early anticipation of clinical manifestations of sepsis which will correlate most with poor outcome.
Sample size:
100 Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.
- Conditions
- Neonatal SEPSIS
- Being tested
- score for neonatal sepsis
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
score for neonatal sepsisDiagnostic test
score for neonatal sepsis to predict morbidity
| Study group | Role | What they receive |
|---|---|---|
| Preterm neonates | Neonates born between 32 and 37 weeks gestation Receives: Diagnostic Test: score for neonatal sepsis | |
| Fullterm neonates | Neonates born at or after 37 weeks gestation Receives: Diagnostic Test: score for neonatal sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Early anticipation of clinical manifestations of sepsis which will correlate most with poor outcome.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Sep 2017
- Primary completion31 Aug 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SEPSISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Ahmed Mahmoud Ali Ali Youssef
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mahmoud Ali Ali Youssef, Cairo University
- Investigators
- Nermin R Mohamed, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746743
- Sponsor's protocol ID
- SNAP II Score
- Acronym
- SNAP
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severity Index of Neonatal Septicemia of Cases Admitted at Neonatal Intensive Care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL Using Score for Neonatal Acute Physiology (SNAP) II
- ClinicalTrials.gov ID
- NCT03746743
- Acronym / sponsor ID
- SNAP / SNAP II Score
- Conditions
- Neonatal SEPSIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ahmed Mahmoud Ali Ali YoussefUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia in the Neonatal Intensive Care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL.
Detailed description
This study will be conducted at the Neonatal intensive care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL.
Population of study \& disease condition:
Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.
Inclusion criteria:
- Type of patient: Neonates with septicemia.
- Age of patient: From 0-28 Days.
- Sex: males and females.
Exclusion criteria:
- Neonates with proved inborn error of metabolism.
- Neonates with multiple congenital anomalies.
- Neonates with severe birth asphyxia (APGAR score <4 at 5 minutes).
Methodology in details:
We will have 2 groups, each of them 50 neonates with septicemia. One group of premature neonates (32-36 weeks), the other group of full term neonates (>37 weeks).
All included Patients will be subjected to the following:
- Full history with emphasis of relevant data as follows: Date of birth, gestational age (AGA or SGA), gender, day of sepsis onset.
- Clinical assessment: Full systems examination.
- Diagnosis of sepsis:
- By abnormal Total leucocytic count or I/T ratio or CRP with clinical Suggestion (poor feeding, hepatomegaly, apnea, tachypnea, lethargy, …).
- Confirm diagnosis by blood culture. Sepsis will be considered severe if the neonate has sepsis plus one of the following: 1) cardiovascular organ dysfunction (hypotension or need for vasoactive drug) 2) 2 of the following (metabolic acidosis, increase lactic acid, oliguria, Prolonged capillary refill time) 3) Organ dysfunction (respiratory, renal, neurologic, hematologic).
- SNAP II score: For all neonates included in the study and its data collection within 24 hours from onset of sepsis, in the form of:
- Lowest mean blood pressure.
- Worst ratio of pao2/fio2
- Lowest temperature.
- Lowest serum PH.
- Occurrence of multiple seizures.
- Urine output<1 ml/kg/hour.
- Follow up: Follow up all neonates included in the study for 14 days: for morbidity and mortality.
- Diagnosis of organ dysfunction:
Respiratory: by CXR and clinical examination. CVS: by blood pressure, capillary refill time, shock and need for inotropes. Renal: by urine output, kidney function tests. Hematology: by picture of DIC or pancytopenia. Neurology: by seizures, dilated fixed pupil.
Possible Risk:
None.
Primary outcomes:
Using Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia.
Secondary outcomes:
Early anticipation of clinical manifestations of sepsis which will correlate most with poor outcome.
Sample size:
100 Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm neonates | – | Diagnostic Test: score for neonatal sepsisNeonates born between 32 and 37 weeks gestation |
| Fullterm neonates | – | Diagnostic Test: score for neonatal sepsisNeonates born at or after 37 weeks gestation |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.
Key inclusion criteria (3 listed)
- Type of patient: Neonates with septicemia.
- Age of patient: From 0-28 Days.
- Sex: males and females.
Key exclusion criteria (3 listed)
- Neonates with proved inborn error of metabolism.
- Neonates with multiple congenital anomalies.
- Neonates with severe birth asphyxia (APGAR score <4 at 5 minutes).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| score for neonatal sepsisscore for neonatal sepsis to predict morbidity | Diagnostic test | Fullterm neonates, Preterm neonates |
Primary outcome
Using Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia.
Time frame: through study completion, an average of 1 year
1 secondary outcome
Early anticipation of clinical manifestations of sepsis which will correlate most with poor outcome.
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nermin R Mohamed, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal SEPSIS, run by Ahmed Mahmoud Ali Ali Youssef at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.